Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response

Completed · Phase 4

Conditions studied: Bradycardia

In brief

This is a randomized, prospective, single-blinded, multi-center study involving approximately 1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness of Closed Loop Stimulation (CLS) rate adaption technology over both standard rate responsive technology (R) and non-rate responsive mode (DDD) during activities of daily living (ADL).

Key facts

Study ID

NCT00355797

Run by

Biotronik, Inc.

People needed

1491

Starts

2006-05-01

Expected to finish

2010-12-01

Last updated by the study team

2012-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Implanted within the last 45 days or being considered for implant with a BIOTRONIK pacemaker utilizing CLS rate adaptation technology (currently the Cylos family of pacemakers).
• Ability to give written informed consent
• Geographically stable and able to return for regular follow-ups for 12 months after ADL testing
• At least 18 years old

You may not qualify if…

• Patients physically limited and unable to perform all or parts of the ADL testing
• Currently enrolled in any other clinical study
• Patients with medical reasons that preclude regular participation in the follow-ups

Where it is running

• Cardiology Associates-Gadsden — Gadsden, Alabama, United States
• North Alabama Cardiology Center — Gadsden, Alabama, United States
• Richard Kim, MD — Jasper, Alabama, United States
• Arizona Heart Institute — Phoenix, Arizona, United States
• N.R. Devaraj, M.D., Inc. — Anaheim, California, United States
• Family Doctor Medical Group — Benicia, California, United States
• Caremore Medical Group — Downey, California, United States
• Multani Medical Group — Downey, California, United States
• Solano Cardiology — Fairfield, California, United States
• Pacific Cardiology Associates — Fremont, California, United States
• San Joaquin General Hospital — French Camp, California, United States
• Kenny Charn, MD — Jackson, California, United States
• Kartik Thaker, MD — Lakewood, California, United States
• Mission Internal Medical Group — Mission Viejo, California, United States
• Cardio-Pulmonary Associates — Monterey, California, United States
• St. Luke Cardiovascular Medical Group — Murrieta, California, United States
• Sacramento Heart & Vascular — Sacramento, California, United States
• Emad Khaleeli, MD — Torrance, California, United States
• Torrance Memorial Medical Center — Torrance, California, United States
• Cardiology Consultants — Turlock, California, United States
• Ventura Cardiology — Ventura, California, United States
• Alireza Jafari, MD — Whittier, California, United States
• Colorado Cardiovascular Center — Boulder, Colorado, United States
• Boulder Medical Center — Boulder, Colorado, United States
• Raymond Fernandez — Albertville, Alabama, United States

Full record on ClinicalTrials.gov

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